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Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.
Achieved serum samples of the different testing groups are retrieved and tested with the immunoassays according to manufacturer's instruction.
The test results are then compared and analyzed with statistical tests to assess the immunoassays'performance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With COVID-19 infection | Subjects with a positive SARS-CoV-2 PCR |
| |
| Without COVID-19 infection | Subjects with COVID-19 negative serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 antibody immunoassays | Diagnostic Test | Different commercial SARS-CoV-2 antibody immunoassays |
|
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of the different commercial SARS-CoV-2 antibody immunoassays | To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays | 1 month |
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Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19 infection
Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2 PCR
Exclusion Criteria:
-
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Patients who attended clinic and had a positive SARS-CoV-2 PCR and subjects who had COVID-19 negative serum during the epidemic in Hong Kong.
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| Name | Affiliation | Role |
|---|---|---|
| Jonpaul Sze Tsing Zee, MBChB | Hong Kong Sanatorium & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Sanatorium & Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |